For many types of medical treatments, the impact and ultimate usefulness of the treatment depends on the patient's tolerability and sensitivity to the treatment. Such measures assist physicians in accurately and efficiently treating patients. To date, however, most medical treatments are provided to the patient based on objective measurements, rather than on actual measurements of the specific subject or environment of the subject.
For example, typical medical treatment parameters for many drug therapies are provided based on the generic circadian system. Under the circadian system it has been know in the medical industry that typical biological functions of plants and animals reoccur at approximately 24-hour intervals. In humans, the body's clock is located in the suprachiasmatic nucleus (SCN), a distinct group of cells found within the hypothalamus. The SCN controls or coordinates the circadian rhythm in the human body. Typically, a human's circadian rhythm is calibrated by the alternation of light through the eyes and darkness via melatonin secretion by the pineal gland.
Furthermore, the cellular metabolism and proliferation in normal human tissues display similar rhythms, and thus have predictable amplitudes and times of peak and trough. Such rhythms influence drug pharmacology, tolerability, and ultimate usefulness. For example, it has been thought that the circadian rhythm influences the uses and effects of anti-cancer medication, including tolerability and anti-tumor efficacy in cancer treatment. Therefore, in chronopharmacologic intervention, anti-cancer drugs are delivered according to a standard circadian rhythm, especially with chemotherapy. For example, Floxuridine delivery is typically given in four doses, each dose dependent on the time of the day:                14% of dose between 9 am and 3 pm;        68% of dose between 3 pm and 9 pm;        14% of dose between 9 pm and 3 am; and,        4% of dose between 3 am and 9 am.        
Generally, the time at which the medication is delivered is selected by the physician to objectively coincide, with changes in the patient's metabolism. However, the circadian rhythm is merely an estimate of the changes in the patient's metabolism, and is not based on the actual patient's metabolism. Thus, whether the medication delivery actually coincides with the patient's actual metabolism is neither evaluated nor determined.
Additionally, different medical treatments have different optimum dosing time-profiles. For example, different anti-tumor drugs are typically dosed at different times: Epirubicin and Daunorubicin are typically dosed at 2 hours after light onset; Cyclophasphamide is typically dosed at 12 hours after light onset; Cisplatin is typically dosed at 15 hours after light onset; and, Vinblastine is typically dosed at 18 hours after light onset. As can be seen, different drugs have different mechanisms of action.
Other factors, however, may also affect proper medical treatment. For example, the minimum sensitivity of normal tissue is thought to be related to the enzyme levels that affect drug metabolism (e.g., glutathione). An overall driver of these variables is thought to be the rest-activity cycle of the patient. Because of this effect, it is known that laboratory rat studies should be conducted with the animal subjected to a 12 hour light, and 12 hour dark cycle.
Nevertheless, it is known that different patients, and with regard to cancer treatment, even different tumors, are not all on the same circadian cycle. Thus, there are at least two aspects one needs to optimize during circadian therapy: (1) the peak sensitivity of the tumor(s); and, (2) the minimum sensitivity of the normal tissues.
Standard chronopharmacologic intervention takes advantage of the circadian rhythm in drug tolerability by controlling the timing and dosing. Thus, it can reduce the effect of toxicity and improve the quality of life for the patient. Furthermore, with many drugs, including chemotherapy drugs, by administering a higher maximum tolerated dose at the least toxic circadian time, an improvement in survival may be derived. However, as explained above, there are numerous flaws with providing medical treatments following the standard circadian system.
Thus, a method and a means for subjectively determining, triggering and controlling the delivery of medical treatments for a specific patient is highly desirable.